Junior controller állások Németországban (minőségbiztosítás)

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

• Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest.
• Give insights into clinical data sets and evidence for our company's products to internal stakeholders.

Execution of consulting projects with a focus on developing market access and dossier strategies, including preparation of corresponding workshops, and participation in oral hearings with relevant authorities...

• Lead the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations

• Drive and complete reimbursement applications for the Vibrant product portfolio
• Build and check health economic models that clearly demonstrate product value by using appropriate software tools

• Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure documentation and validation of systems according to internal procedures
• Ensure compliance with internal and external regulatory requirements and guidelines
• Maintain the inventory of software applications

In your new role, you will define and implement the global strategy for analytical development, supporting BI's pipeline from early research through candidate characterization and selection to drug product development and launch....

• Author, own and maintain internal guidance and training documentation
• Collaborate with various functions within the global company, internal and external suppliers and with customers with the objective to share expertise and provide guidance

• Oversee work for timely completion of a complaint investigation and response to the various customers
• Communicate with customers regarding complaints, product issues and returned devices